We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Abbott Diagnostics

Download Mobile App





Novacyt's Two-Hour Coronavirus Test Gains FDA Emergency Use Approval

By LabMedica International staff writers
Posted on 04 Apr 2020
Print article
Image: Novacyt’s real-time polymerase chain reaction (PCR) COVID-2019 IVD-CE test (Photo courtesy of Novacyt S.A.)
Image: Novacyt’s real-time polymerase chain reaction (PCR) COVID-2019 IVD-CE test (Photo courtesy of Novacyt S.A.)
Novacyt S.A. (Paris, France), a specialist in clinical diagnostics, has secured Emergency Use Authorization from the FDA for its fast and easily transportable COVID-19 test which was developed by Primerdesign, its molecular diagnostics division.

The Novacyt Group is an international diagnostics business generating an increasing portfolio of in vitro and molecular diagnostic tests. Its core strengths lie in diagnostics product development, commercialization, contract design and manufacturing. The company's lead business units comprise of Primerdesign and Lab21 Products, supplying an extensive range of high-quality assays and reagents worldwide. The Group directly serves microbiology, hematology and serology markets as do its global partners, which include major corporates.

Novacyt’s real-time polymerase chain reaction (PCR) COVID-2019 IVD-CE test detects viral genetic material, RNA, collected through a swab test of the nose or throat. The RNA is isolated from the sample and detected using qPCR, which amplifies genetic material. As compared to RNA detection methods used for confirming the virus in patients that takes up to four hours to deliver results and require specialized equipment, Novacyt’s test only detects the SARS-CoV-2 virus and produces results in less than two hours. The test is also designed to run on multiple instrument platforms used by clinical laboratories globally, ensuring that it can be used by a large number of clinicians. The company freeze-dries its kit reagents to ensure easy transport and storage, making its test suitable for tropical climates and low-resource settings.

Novacyt’s real-time polymerase chain reaction (PCR) COVID-2019 IVD-CE test is validated for use on the GenoXtract automated nucleic acid extraction device and associated extraction kits from Bruker-Hain Diagnostics, the molecular diagnostics products business unit of Bruker Corporation (Billerica, MA, USA). It is also under validation on Bruker’s new FluoroCycler XT PCR instrument, allowing Bruker to provide a full solution from automated extraction to result. Novacyt has signed a global distribution agreement for its COVID-19 test with Bruker-Hain Diagnostics.

Additionally, Novacyt has signed an agreement for certain contract manufacturing services with Yourgene Health Plc (Camberley, UK), an international molecular diagnostics group, which will provide support for the production of the COVID-19 diagnostic test.

Related Links:
Novacyt S.A.
Bruker Corporation
Yourgene Health Plc



Print article

Channels

Microbiology

view channel
Image: Stenotrophomonas maltophilia colonies on sheep blood agar. Cultivation 48 hours in an aerobic atmosphere, 37 °C (Photo courtesy of microbiologyinpictures).

Global Spread of the Multi-Resistant Pathogen Stenotrophomonas Maltophilia Revealed

Stenotrophomonas maltophilia strains occur in several natural and human associated ecosystems. The bacterium was long regarded as relatively unproblematic, but is now considered to be one of the most feared... Read more
Copyright © 2000-2020 Globetech Media. All rights reserved.